English to Russian Medical Medical: Pharmaceuticals

1.2 Aluminum
The aluminium concentration of 13vPnC drug product is determined by Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), and is intended to ensure the appropriate adjuvant concentration in the final formulation.
Table 1-4 summarizes the pilot and commercial scale batch data used to support the specification and includes the calculated tolerance interval to demonstrate process capability.
The calculated *TI interval* extends below the proposed specification of 0.20 – 0.30 mg/mL; however, manufacturing history demonstrates the ability to meet the proposed specification.